Mismanaged IVF inventory is driving compliance exposure, revenue loss, and operational strain across U.S. fertility labs

This News Digest Story is paid featured content.

BY INSIDE REPRODUCTIVE HEALTH

A growing volume of unclaimed, mislabeled, and undocumented specimens is creating a quiet but escalating crisis in fertility labs nationwide. Between legacy recordkeeping systems and inconsistent follow-up with patients, IVF clinics are amassing thousands of embryos and gametes in limbo—adding legal risk, regulatory scrutiny, and financial burden to an already strained infrastructure.

Estimates suggest that 5% to 18% of all cryopreserved embryos in the U.S. may be unclaimed, equating to tens of thousands of specimens with no clear path forward. Clinics often hesitate to discard these materials due to legal uncertainties around consent and disposition, leaving them in storage for years without reimbursement. With annual cryo storage fees typically ranging from $500 to $1,000 per specimen, the cost of retaining nonviable or abandoned material is rising rapidly.

The operational impact is compounding. Labs are responsible for the physical integrity and accurate tracking of every specimen. When records don’t match what’s in the tanks—or when specimens go unclaimed—it adds hours of manual reconciliation, interrupts workflows, and puts staff under compliance pressure.

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Documentation Gaps, Mix-Ups Increasingly Risky

The mismanagement of cryo inventory extends beyond cost inefficiencies. Incomplete or outdated records heighten the risk of catastrophic identification errors. In one widely publicized case, a woman gave birth to another couple’s child following an IVF lab mix-up—underscoring the profound implications of mislabeling or poor tracking.

Despite mounting risk, some fertility clinics continue to rely on outdated tools—primarily spreadsheets and disconnected databases—to manage cryopreserved material. Internal audits remain largely manual and error-prone, while competing digital platforms often inherit the flaws of inaccurate baseline data.

Lab directors are often stuck cleaning up a decade’s worth of someone else’s documentation. And with storage demands climbing, the pressure isn’t letting up. The American Society for Reproductive Medicine has acknowledged these strains, noting that clinics are “challenged by the physical maintenance of continuously-expanding storage facilities” and by the “difficulty of maintaining records for logging and tracking the cryopreserved specimens.”

Disorganized Inventory Undermines Clinics’ Tech Stacks

While labs rush to adopt AI, RFID, and automation, the lack of clean baseline inventory undermines their value. AI-assisted embryo selection, robotic cryopreservation, and digital witnessing platforms can only function effectively if the data input is accurate and complete.

The industry is also seeing increasing attention from insurers and regulators—raising the stakes for labs operating without clear, reconciled records. Clinics that hope to future-proof their operations must first address the underlying disorder in their inventory systems.

Inventory Audits Become Strategic Linchpin for IVF Labs

CryoFuture, a neutral third-party specializing in cryogenic inventory audits, is offering what many see as a critical reset. Unlike software vendors that layer on digital platforms, CryoFuture begins with physical inventory validation—auditing tanks, verifying consents, and tagging specimens with RFID before enabling digital transition.

Dr. Sheela Ali, PhD, HCLD/TS/CC (ABB), Scientific Director – IVF laboratories says, “As an experienced IVF laboratory director, I found the physical inventory audit and validation service performed by CryoFuture’s team of experienced embryologists, invaluable - streamlining our operations without disrupting patient care and allowing our embryologists to stay focused on what matters most.”

Their methodology draws from regulated biobanking best practices, including double-witnessing, documentation alignment, and reconciliation of ownership history. By operating as an extension of the lab team, they help clinics uncover gaps, reduce liability, and reclaim control over their storage environments.